BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMERGE

    MDR report key: 17721235 · Received September 11, 2023

    Report

    Report Number
    2124215-2023-49342
    Event Type
    Malfunction
    Date Received
    September 11, 2023
    Date of Event
    September 1, 2023
    Report Date
    September 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BALLOON RUPTURE OCCURRED. A 2.50MM X 12MM EMERGE BALLOON CATHETER WAS ADVANCED FOR DILATATION. HOWEVER, THE BALLOON RUPTURED DURING KISSING-BALLOON TECHNIQUE (KBT) WITH A NON-BOSTON SCIENTIFIC STENT BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144002 EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION 7162 0030202826

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown